Bindu Harshini Cherukuri
Phillips Medisize, 1-6 Prospect West, Bumpers Way, Chippenham, SN14 6FH
Summary
Nitrosamines are a significant concern in pharmaceutical products because they are classified as probable human carcinogens, with regulatory agencies taking steps to address this issue. It is important for pharmaceutical companies to consider strategies for the reduction or prevention of nitrosamine drug substance-related impurities (NDSRIs) to avoid and mitigate the risk of nitrosamine presence in their products. These may include selecting excipients (suppliers or batches) with lower nitrite levels or incorporating antioxidants into drug products to reduce nitrosamine formation.
The Phillips Medisize proprietary open-inhale-close (OIC) multidose dry powder inhaler (DPI) uses a blister strip to contain the individual doses of drug product, incorporating a lidding foil that has the potential to contain nitrosamine-related impurities. This blister strip lidding foil has now been upgraded to a nitrocellulose (NC)-free foil for a model product in ongoing stability studies, at long-term and accelerated ICH storage conditions.
All results relating to and influenced by the foil’s moisture barrier properties from NC-free foil blister strip were compared against the original foil blister strip in this stability study. Moisture content, related substances, delivered dose (DD) and aerodynamic particle size distribution (APSD) results from NC-free foil blister strip product are comparable to the results from the original foil blister strip product (12 months, long-term and 26 weeks, accelerated). In conclusion, the NC-free foil blister strip product demonstrates equivalent product performance to the original foil blister strip for the OIC DPI model product.